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Timely and Effective Premarket Review OCP Requirements

FY 2008 OCP Performance Report

Requirement:  Report the Number and Types of Combination Products under Review

FDA is to report the number and types of combination products under review. The following information refers to FDA performance presented in this subsection.

  • The number and types of combination products under review for FY 2008 by CBER, CDER, and CDRH included submissions FDA filed in FY 2008. The number of combination product submissions is a small subset of the total number of submissions received by FDA.
  • When reporting timeliness in days of the review for CBER-led or CDER-led combination products, PDUFA goals were referenced for priority and standard new drug applications (NDAs) and biologics license applications (BLAs). With CBER-led or CDRH-led combination products, MDUFA II Tier 2 decision goals were referenced for expedited and original premarket approval applications (PMAs) and premarket notifications [510(k)s].6 Because no priority and standard BLA goals were included in MDUFA II, MDUFMA I BLA decision goals for FY 2007 were referenced. Performance goals apply to only a subset of applications of a certain type. Therefore, not every application is required to be reviewed in accordance with a user fee related time frame.
  • Some product review goals, such as NDAs, are defined by number of months. Due to the fluctuation in days of individual months (28 to 31), 10 months represents a range from 303 days (February 1 to December 1) to 306 days (March 15 to January 15), and 6 months represents a range from 182 days (February 15 to August 15) to 184 days (July 15 to January 15).
  • Median review time was based on FDA first cycle review performance for PDUFA goals. For MDUFA II goals, median review times were based on total MDUFA II decision review time, except for BLAs where total decision review time was based on MDUFMA I goals. Actual review time was used when only one action was measured.
  • All performance data in this report reflects FDA actions completed through September 30, 2008, unless otherwise specified.

The table below reflects 330 original applications for NDAs, BLAs, PMAs, 510(k)s, investigational new drugs (INDs), investigational device exemptions (IDEs), and humanitarian use exemptions (HDEs) initially classified into one of nine categories of combination products received in FY 2008.7

Number and Types of Combination Products

Application Type Combination Product Category Totals
1 2 3 4 5 6 7 8 9
Original NDAs 1 10 -- -- -- -- 3 -- -- 14
Original BLAs -- -- 4 -- -- -- -- -- -- 4
Original PMAs -- -- -- 1 -- -- -- 1 -- 2
Original 510(k)s 11 -- -- 83 11 -- 1 -- 14 120
Original INDs -- 49 18 9 6 15 8 38 15 158
Original IDEs 1 -- 1 13 3 -- 4 9 1 32
Original HDEs -- -- -- -- -- -- -- -- -- 0
Totals 13 59 23 106 20 15 16 48 30 330

APPLICATION KEY:
NDAs = New Drug Applications
BLAs = Biologics License Applications
PMAs = Premarket Approval Applications
510(k)s = Premarket Notifications
INDs = Investigational New Drug Applications
IDEs = Investigational Device Exemptions
HDEs = Humanitarian Device Exemptions

COMBINATION PRODUCT KEY:
1 = convenience kit or co-package
2 = prefilled drug delivery device/system
3 = prefilled biologic delivery device/system
4 = device coated/impregnated/otherwise combined with drug
5 = device coated or otherwise combined with biologic
6 = drug/biologic combination
7 = separate products requiring mutually conforming labeling
8 = possible combination based on mutually conforming labeling of separate products
9 = other type of combination product


Workload

Of the 330 original combination product applications, 54 applications were classified as CBER-led combination products; 123 applications were classified as CDER-led combination products; and 153 applications were classified as CDRH-led combination products.

FY 2008 Combination Product Appilcations

Requirement: Report the Timeliness in Days of the Reviews of Combination Products

FDA is to report the timeliness in days of the reviews of combination products. The table below summarizes the review type and review performance target for original NDAs, BLAs, PMAs, and 510(k)s. PDUFA and MDUFA II established review performance goals for many types of drug, device, and biological product premarket applications. These goals reflect current expectations about the portion of premarket applications that will be reviewed within a specified time frame. Performance goals apply to only a portion of all applications of a certain type, and they do not require that every application be reviewed in accordance with the applicable time frame.

User Fee Act Original Application Type Review Type Review Within Performance Level
PDUFA NDAs Priority 6 months 90%
Standard 10 months 90%
BLAs Priority 6 months 90%
Standard 10 months 90%
MDUFA II Expedited PMAs MDUFA II decision 280 days 90%
PMAs MDUFA II decision 295 days 90%
510(k)s SE or NSE decision 150 days 98%
BLAs* Priority 6 months 90%
Standard 10 months 90%

* No specific performance goals for BLAs were provided under MDUFA II; therefore, the performance goal from FY 2007 under MDUFMA I was referenced.

FDA review performance information, with respect to premarket review, for CBER, CDER, and CDRH are based on a fiscal year receipt cohort. This methodology calculates performance information for submissions for the fiscal year FDA received them, regardless of when FDA acted on or approved the submissions. This section updates FDA’s review performance on the FY 2007 combination product submissions and presents FDA’s review performance on the FY 2008 combination product submissions through September 30, 2008.


Performance (CBER-led or CDER-led Combination Products)

FY 2007 Submissions

FDA reviewed and acted on all (16 of 16) submissions identified as CBER-led or CDER-led combination products (see table below). These actions included 4 priority and 9 standard NDA combination product submissions and 3 standard BLA combination product submissions.

Original Application Type Review Type Review Within (Months) Number of Combination Products Reviewed and Acted On Number on Time Median or Actual Review Time (Days) Range of Review Time (Days)
Min Max
NDAs Priority 6 4 4 4 183 180 183
Standard 10 9 9 7 304 265 438
BLAs Priority 6 0 0 -- -- -- --
Standard 10 3 3 3 297 260 303

 

FY 2008 Submissions

As of September 30, 2008, FDA reviewed and acted on 7 of 18 submissions identified as CBER-led or CDER-led combination products (see table below). These actions included two priority and four standard NDA combination product submissions and one standard BLA combination product submission. Additional NDA and BLA combination product submissions were under review, with decisions pending.

Original Application Type Review Type Review Within (Months) Number of Combination Products Reviewed and Acted On Number on Time Median or Actual Review Time (Days) Range of Review Time (Days)
Min Max
NDAs Priority 6 2 2 2 181 180 182
Standard 10 12 4 4 305 280 305
BLAs Priority 6 0 0 -- -- -- --
Standard 10 4 1 1 281 281 281


Performance (CBER-led or CDRH-led Combination Products) 

FY 2007 Submissions

FDA reached decisions on 106 of 107 submissions identified as CBER-led or CDRH-led combination products (see table below). These decisions included 5 original PMA combination product submissions and 101 510(k) combination product submissions. One 510(k) combination product submission was under review, with a decision pending.FY 2008 Submissions

Original Application Type Review Type Review Within (Days) Number of Combination Products Decisions Reached Number on Time Median or Actual Review Time (Days) Range of Review Time (Days)
Min Max
Expedited PMAs FDA decision 280 0 0 -- -- -- --
PMAs FDA decision 295 5 5 3 224 148 419
510(k)s SE or NSE 150 102 101 95 64 2 269

 

FY 2008 Submissions

As of September 30, 2008, FDA reached decisions on 102 of 122 submissions identified as CBER-led or CDRH-led combination products (see table below). All decisions made were on 510(k) combination product submissions, which have shorter review times. Additional PMA and 510(k) combination product submissions were under review, with decisions pending.

Original Application Type Review Type Review Within (Days) Number of Combination Products Decisions Reached Number on Time Median or Actual Review Time (Days) Range of Review Time (Days)
Min Max
Expedited PMAs FDA decision 280 1 0 -- -- -- --
PMAs FDA decision 295 1 0 -- -- -- --
510(k)s SE or NSE 150 120 102 102 69 4 150

 

Requirement:  Report the Number of Premarket Reviews of Combination Products that Involved a Consulting Center  

FDA is to report the number of premarket reviews of combination products that involved a consulting Center. The table below reflects the Intercenter Requests for Consultative or Collaborative Review forms received and monitored by OCP during FY 2008. 8

Primary Assigned Center Consulting Center Number of Consults
CBER CDER CDRH
CBER -- 13 37 50
CDER 1 -- 77 78
CDRH 7 236 -- 243
Totals 8 249 114 371

As the primary assigned Center, CBER requested 50 intercenter consultations (13 consultations with CDER and 37 consultations with CDRH); CDER requested 78 intercenter consultations (1 with CBER and 77 with CDRH); and CDRH requested 243 intercenter consultations (7 with CBER and 236 with CDER).

 

 

6 Under MDUFA II, Tier 2 goals focus on completing the majority of reviews within longer time frames.
7 The “Number and Types of Combination Products” received in FY 2007 are updated in Appendix A to reflect corrections and actions as of September 30, 2008.

8 Some applications were associated with multiple consulting requests. Additionally, because these consulting requests are associated with any combination product under review for which consultative or collaborative review is needed, regardless of the date of FDA receipt of the application, the number of requests is not directly comparable to the number of combination product applications received during FY 2008, as reported in the previous section.

Next page: Effective Resolution of Review Disputes